Study to Evaluate Vectical in Combination With Clobex Spray to Treatment Plaque Psoriasis
NCT ID: NCT01205880
Last Updated: 2010-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
12 participants
INTERVENTIONAL
2009-12-31
2010-01-31
Brief Summary
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Detailed Description
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All subjects will be consented prior to any study evaluations/procedures. Study evaluations including Target Lesion Severity Score (TLSS) and photography will be performed at Baseline/Day 0, week 2 and week 4.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
SINGLE
Study Groups
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vectical ointment and clobex spray
patients were assigned to apply vectical ointment first then clobex spray on one target lesion and also apply clobex spray first then vectical ointment on a different target lesion on the opposite side of the body.
Calcitriol ointment
twice daily
Clobetasol spray
twice daily
Interventions
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Calcitriol ointment
twice daily
Clobetasol spray
twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Females of childbearing potential must have a negative urine pregnancy test on Baseline/Day 0 and must agree to use adequate birth control methods during the entire study (a barrier method {condoms, diaphragm}; hormonal contraceptives {birth control pills, implants \[Norplant\] or injections \[DepoProvera\]}; intrauterine device {IUD}; or abstinence {no sexual activity}).
3. Subjects must be diagnosed with plaque psoriasis affecting \< 20% body surface area, with at least one discreet plaque on the each side of the body (excluding the face, scalp, groin, axillae or other intertriginous areas).
4. Subjects must have at least 2 lesions suitable for evaluating response to test agents (one on the right side and one on the left side of the body). The severity of the disease for each target lesion at Baseline/Day 0 must be rated at least 2 (Mild) for each of the key psoriasis characteristics (scaling, erythema, and plaque elevation).
5. Subjects must be able to understand the requirements of the study abide by the restrictions and return for the required examinations.
Exclusion Criteria
2. Subjects with known hypersensitivity to any components of the test medication.
3. Subjects with non-plaque psoriasis (e.g. guttate, erythrodermic) or other related diseases not classified as plaque psoriasis.
4. Subjects whose psoriasis involves only the scalp, face, groin, axillae, and/or other intertriginous areas.
5. Subjects who have surface area involvement too large (\>20% BSA) that would require more than 59 ml/week (50 g/week) of Clobex® spray and/or more than 200 g/week of Vectical® ointment.
6. Subjects requiring any other medication (topical or systemic) that may affect the course of the disease during the study period as determined by the study investigators.
7. Subjects using biologics or any other systemic treatment (e.g. immunosuppressants, acitretin) for psoriasis within 12 weeks of entering the study.
8. Subjects using systemic corticosteroids within 28 days of entering the study
9. Subjects using topical corticosteroids or other topical therapies (other than emollients) at the target area locations within 2 weeks of entering the study
10. Subjects using phototherapy (UVB, PUVA) within 4 weeks of entering the study.
11. Subjects with overt pre-existing telangiectasias or skin atrophy at intended treatment sites (target areas).
12. Subjects with intakes of more than 2,000 IU/day (50 mcg/day) of vitamin D (tolerable upper intake level) and/or more than 1,000 mg/day of calcium (based on Dietary Reference Intakes developed by the Institute of Medicine of the National Academy of Sciences).
13. Subjects who have participated in another investigational drug or device research study (at the target areas) within 30 days of enrollment.
14. Subjects who are using any medication or has any disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study.
18 Years
ALL
Yes
Sponsors
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Galderma Laboratories
OTHER
Emer, Jason, M.D.
INDIV
Responsible Party
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Mount Sinai School of Medicine
Principal Investigators
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Jason J Emer, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Mount Sinai School of Medicine
New York, New York, United States
Countries
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References
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Jarratt MT, Clark SD, Savin RC, Swinyer LJ, Safley CF, Brodell RT, Yu K. Evaluation of the efficacy and safety of clobetasol propionate spray in the treatment of plaque-type psoriasis. Cutis. 2006 Nov;78(5):348-54.
Beutner K, Chakrabarty A, Lemke S, Yu K. An intra-individual randomized safety and efficacy comparison of clobetasol propionate 0.05% spray and its vehicle in the treatment of plaque psoriasis. J Drugs Dermatol. 2006 Apr;5(4):357-60.
Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb A, Koo JY, Lebwohl M, Lim HW, Van Voorhees AS, Beutner KR, Bhushan R; American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009 Apr;60(4):643-59. doi: 10.1016/j.jaad.2008.12.032. Epub 2009 Feb 13.
Abramovits W. Calcitriol 3 microg/g ointment: an effective and safe addition to the armamentarium in topical psoriasis therapy. J Drugs Dermatol. 2009 Aug;8(8 Suppl):s17-22.
Bruner CR, Feldman SR, Ventrapragada M, Fleischer AB Jr. A systematic review of adverse effects associated with topical treatments for psoriasis. Dermatol Online J. 2003 Feb;9(1):2.
Other Identifiers
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08-1500
Identifier Type: -
Identifier Source: org_study_id